1. Technical Field
This invention relates to the field of nutritional supplementation. Specifically, this application describes and claims a nutritional supplement which is specifically tailored to provide nutritional support to an individual during the pre- and post-operative or pre- and post-procedure period (the peri-operative period). The supplements described here may be administered to any person in need of nutritional supplementation, however persons undergoing surgical operations or other types of procedures which cause a stress on the body or persons who have suffered an injury can particularly benefit from the inventive compositions, which promote healing in such persons.
2. Description of the Background Art
The nutritional status of patients affects the outcome of their surgical or interventional procedures, or their response to trauma. One large study documented that at least one complication occurs in 17 percent of surgical patients. The overall risk for surgical complications depends on many individual factors and the type of surgical procedure, however malnourishment or sub-optimal nourishment is an important factor in the incidence of complications. Malnourished patients experience increased morbidity and mortality when faced with the stresses of surgery, interventional procedures, or trauma.
Although the pre-operative or pre-procedure history and physical examination should include an assessment of risk factors for malnutrition, especially in the elderly, nutritional status and the need for nutritional supplementation is hardly ever addressed. While laboratory tests, such as serum albumin and total lymphocyte count, may aid in the diagnosis of malnutrition, other factors should be considered. Social isolation, limited financial resources, poor dentition, weight loss and chronic disorders such as pulmonary disease, congestive heart failure, depression, cognitive disorders, diarrhea, and constipation are commonly associated with malnutrition. In addition, patients often do not and/or cannot eat well for varying periods before and after surgery due to the condition requiring intervention, further compromising nutritional status. Finally, patients are faced with bewildering and often conflicting sources of information concerning nutrition and other factors that would facilitate their speedy and uneventful recovery.
Steps can be taken using natural approaches to strengthen the body before and/or after surgery, interventional procedures, and after injury to enhance defenses, prevent complications, and speed recovery. The wrong choice(s) of nutritional supplementation, however, may have a negative impact on peri-operative or peri-procedure patient care or on general nutrition. For example, Echinacea, ephedra, garlic, gingko, ginseng, kava, St. John's wort, and valerian root are commonly used herbal supplements that may be a reason for concern during the peri-operative and peri-procedure period. Complications can arise from these herbs' direct and/or pharmacodynamic or pharmacokinetic effects. Direct effects include bleeding from garlic, gingko, and ginseng, cardiovascular instability from ephedra, and hypoglycemia from ginseng, both of which can be dangerous in any individual who may suffer trauma such as that which occurs in injury, surgery or other invasive procedures. Pharmcodynamic herb-drug interactions include potentiation of the sedative effect of anesthetics by kava and valerian root. Pharmacokinetic herb-drug interaction also may induce increased metabolism of many drugs used in the peri-operative or peri-procedure period, for example with St. John's wort.
Micronutrients are elements or compounds which are present in foods in small or trace amounts and include vitamins, minerals or other elements. These micronutrients include compounds such as pantothenic acid, biotin and choline that are found in foods but for which a Recommended Dietary Allowance (RDA) has not yet been determined. Some elements such as Calcium, Sodium, Potassium, Chloride and Phosphorus are consumed in relatively large amounts, while many such as Iron, Iodine, and Zinc are consumed in small amounts (milligrams). Vitamins such as Vitamin B12, and folic acid and the minerals Copper, Selenium and Chromium are consumed in very small, or trace amounts (micrograms). Because the human body does not synthesize many of these micronutrients, they must be obtained from exogenous sources. Micronutrients are an important component of nutrition and are often present in sub-optimal or borderline amounts in the diet of any individual, at least occasionally. During periods of stress to the body, such as illness, injury or stressful surgical or other procedures, levels of these micronutrients may fall below the level necessary for optimal healing.
The primary source of all nutrients is food. Ample evidence documents that a large number of persons of different ages, genders and socioeconomic status cannot or do not obtain the Recommended Dietary Allowance of one or more essential micronutrients from their diet. Furthermore, substantial segments of the population do not demonstrate desirable eating patterns, that is, an adequate intake of the quantity or variety of food to fulfill the Recommended Dietary Allowances. In particular, large groups do not consume the recommended number of dietary servings of fruits and vegetables each day. Other factors such as smoking, physical inactivity, exposure to toxic environmental compounds, the avoidance of certain foods and illness or injury can also contribute to low or deficient intake or absorption of nutrients.
In general, many women do not meet the RDAs for 6 out of 15 micronutrients (B6, vitamin E, Calcium, iron, magnesium and Zinc). Men often fail to meet the RDAs for 4 of 15 micronutrients (B6, vitamin E, magnesium and Zinc). There also is a significant prevalence and incidence in various population subgroups of deficiencies in specific vitamins and minerals, some of which are related to micronutrient deficiency diseases such as scurvy (vitamin C deficiency), pellagra (niacin deficiency), beri-beri (vitamin B1 deficiency), iron deficiency anemia and other vitamin and mineral deficiency states. Thus, vitamin and mineral supplementation has become a recognized method of meeting accepted medical and public health nutrition standards for the general population and/or specific populations. Marginal vitamin and mineral deficiency states, in which the blood or tissue levels are in the low range, may occur without the presence of overt physical signs of deficiency disease, but can result in slow healing or increased incidence of complications from surgery or other procedures.
The nutritional status of a person affects the ability to heal. Yet injury and many medical and dental procedures cause serious stress to the body, often leaving the body in a state of nutritional insufficiency. The body's immune system is weakened and gastrointestinal function is often changed, leaving the body vulnerable to infection and in a state of nutritional insufficiency, thus compromising wound healing and delaying the rate of recovery. Harmful nutritional deficiency is even more likely when the person already is in a state of marginal or sub-optimal nutrition prior to the injury or procedure and when the person is unable to eat normally due to the procedure, for example after oral or gastrointestinal surgery.
It is essential for patients to have proper nutritional supplementation in the peri-operative, peri-procedure, and post-trauma period (and generally) to facilitate wound healing and to expedite recovery while at the same time avoiding those supplements with detrimental or deleterious effects. Therefore, it would be of substantial benefit to provide a nutritional supplement formulation and system which overcomes these deficiencies and is able to provide correct nutritional support for men and women of all ages to promote general health and to maximize the ability to heal and withstand trauma, injury or invasive procedures.